Tuesday, April 24, 2012

IS YOUR 'CHECK ENGINE' LIGHT ON?

A VIEW FROM THE OFFICE




IS YOUR 'CHECK ENGINE' LIGHT ON?

     Have you ever been annoyed by your car's 'check engine' light? I mean, have you responded to this light and taken the car in to be checked, only to find there  was nothing really wrong and nothing to be done. [This analogy is provided by Dr. H. Gilbert Welch in his book "Overdiagnosis: Making People Sick in the Pursuit of Health".] The problem now is that your car is so computerized that it even has sensors to detect the function of other sensors. At a certain degree of complexity something has to be at least slightly askew a large fraction of the time. The point that Dr. Welch makes is that getting frequent recommended medical check-ups produces essentially the same result. Your doctor will likely tell you on most of these occasions that "you're 'check engine' light is on" and there's something you have to do to turn it off (despite the often overwhelming odds that everything is just fine). Examples of such situations include the mammogram or chest x-ray with a "suspicious spot," the Pap smear with minor abnormalities like "ASCUS," the stool blood test that is positive (due to hemorrhoids, which are much more common than colon cancer), the blood pressure that is elevated 10 mm Hg more than usual, the freckle that looks just slightly darker than all the other ones, etc. The question for you the patient should be, How often are you metaphorically willing to have your engine checked? It can get to be quite a nuisance. Even more than that, as Dr. Welch points out, it can at times be frankly hazardous to your health.

     Consider this table that he provides for us [his table 2.1]. In it he shows the effects when, hopefully, well-meaning "experts" decide to change the criteria for diagnosis of common conditions. Their imputed motivation for doing this is to catch more people with this condition [i.e., their 'check engine' light is on], so that we might prevent more bad disease outcomes like blindness from diabetes, stroke from hypertension, a heart attack for high cholesterol, and a compression fracture from osteoporosis. The problem is that at the lower range of these physiological variables there are actually a few bad outcomes, but only a very few. As you can see in the table, as you lower the threshold for diagnosing diabetes, hypertension, high cholesterol, and osteoporosis, you are instantly creating literally millions of patients with a "new" disease condition. They are now "sick" and are expected to get "treatment." Only a small percent of such newly diagnosed patients (typically 1-8%) will benefit from this treatment; essentially, a minimum of 92% of the new diagnoses are being subjected to medical scrutiny, testing, and treatment with absolutely no benefit to show for it.

.
CONDITION
PREVALENCE
NEW CASES
% INCREASE

Old criterion
New Criterion


Diabetes: the criterion for diagnosis was changed from a sugar level of 140 down to 126 mg%.
 11,697,000
13,378,000
1,681,000
14%
Hypertension: the criterion for diagnosis was changed from 160/100 to 140/90 mm Hg.
38,690,000
52,180,000
13,490,000
35%
High cholesterol: the criterion for  diagnosis was changed from a total cholesterol of 240 mg to 200 mg/dL.
49,480,000
92,127,000
42,647,000
86%
Osteoporosis: The criterion for diagnosis was changed from a “T score” of 2.5 to 2.0
8,010,000
14,791,000
6,781,000
85%

The other problem is that the motivation for these new diagnostic criteria among the "experts" is not always beneficent. Often it is frankly commercial. "The head of the diabetes cutoff panel was a paid consultant to Aventis Pharmaceuticals, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Novartis, Merck, and Pfizer--all of which make diabetes drugs. Nine of the eleven authors of recent high blood pressure guidelines had some kind of financial ties--as paid consultants, paid speakers, or grant recipients--to drug companies that made high blood pressure drugs. Similarly, eight of the nine experts who lowered the cholesterol cutoff were paid consultants to drug companies making cholesterol drugs. and the first cutoff for osteoporosis was established by a World health Organization panel in partnership with the International Osteoporosis Foundation--an organization whose corporate advisory board consisted of thirty-one drug and medical equipment companies."
     Dr. Welch summarizes the outcomes for persons affected by these new guidelines in this table: 

“If 100 patients are diagnosed on the basis of elevated but near normal levels of a variable and treated for a lifetime, there will be…”
CONDITION
WINNERS
(avoided a heart attack)
TREATED FOR NAUGHT (had a bad outcome despite treatment)
LOSERS
(not helped because they were never going to have a heart attack anyway)
Mildly elevated cholesterol
8
14
78
Mildly low T score for osteoporosis
5
44
51


     This problem also exists with all our fancy new imaging technologies like CT scans and MRIs, as well as for old technologies like plain x-rays and ultrasounds. Here are some typical examples:
  • "Gallstones: In people without any symptoms of gallbladder disease (pain, nausea, or problems with fatty foods, for example), about 10% have gallstones when scanned by ultrasound.
  • "Damaged knee cartilage: In people without knee pain or a history of knee injury, about 40% have meniscal damage in their knees when scanned by MRI.
  • "Bulging discs in the back: In people without any back pain, over 50% have bulging lumbar discs when scanned by MRI."
     And, of course, as I have said in prior blogs, this problem applies to cancer screening. I have already covered prostate cancer, cervical cancer, colon cancer, and breast cancer. Let's take a look at 3 other relatively common cancers--thyroid cancer, melanoma, and lung cancer. 

Thyroid cancer: Thyroid cancer is responsible for about 1,600 deaths each year in the US. The number of cases of thyroid cancer diagnosed each year in the US is much greater       --37,000 cases. This discrepancy is explained by two basic factors:  (1) treatment for the most common thyroid cancers is pretty good; and (2) there is a large portion of thyroid cancers that exist in asymptomatic patients and which is never going to cause any symptoms. In  one autopsy study of 101 older patients who had died of other causes in a hospital, pathologists found clusters of thyroid cancer cells in a full 33% of patients. The researchers in this study concluded that "the smallest forms of thyroid cancer were so common that they should be regarded as normal findings." The moral of this story is that you don't really want your doctor examining your neck (thyroid gland) for lumps because nodules are extremely common (now that we use ultrasound routinely; prevalence is 30-65%), yet death from thyroid cancer is very rare. The United States Preventive Services Task Force recommended against any form of routine thyroid cancer screening in 1996.

Melanoma: There are about 8,400 deaths in the US each year from malignant melanoma. The incidence of melanoma, however, is much higher--around 116,000 cases per year. In recent years there have been many efforts directed at increasing early diagnosis of melanoma and these have resulted in a doubling of the number of cases diagnosed between 1975 and 2005. It would seem like that should be a good thing. But when you look at the annual death rate from melanoma in the same period there has been absolutely no change. This means that all of these extra diagnoses have not reduced the death rate. We have just labelled more people with a diagnosis of melanoma that was going to have no effect on the overall death rate. What we are finding with our increased tendency to biopsy pigmented lesions is that there are many people who have microscopic clusters of abnormal melanin-producing cells who were never going to have any clinical disease from it. Increased screening does not appear to be helping at all. 

Lung cancer: "From a public health perspective, lung cancer is the cancer that warrants the most attention. It's responsible for 162,000 deaths annually in the US. That's more than breast cancer, prostate cancer, melanoma, thyroid cancer, and colon cancer combined. About 215,000 Americans get the diagnosis annually. That means most people diagnosed with lung cancer die from it." Since we know that people who smoke or used to smoke are the ones who have the highest risk for lung cancer, you would think it might make sense to screen this group of patients for lung cancer. If so, you would be wrong.
     Three randomized trials completed in the 1990s showed the screening chest x-rays did not lead to a reduction in lung cancer deaths. "In fact, in two of the studies, screening appeared to cause more deaths." Virtually all cases identified by screening underwent surgery, and the surgery has a significant mortality rate. But this is not the only problem. The other problem is that, after 20 years of follow-up, it appears that approximately 50% of all cancers detected by screening were lung cancers that were small and were never going to cause a problem, yet almost all of these "overdiagnosed" patients underwent surgery.

     Finally, there is the problem of "incidentalomas". This is a new term in medical jargon that refers to abnormal findings on an imaging procedure that was carried out for a purpose unrelated to cancer screening. For example, if a chest CT scan is done for a pulmonary problem, it may also unexpectedly find a "spot" in the liver or kidney. If an ultrasound is done on a carotid artery to assess circulation, it may also see a cyst or nodule in the thyroid gland. 

.
Organ
% of people with an incidentaloma on CT scan
10-year risk of cancer death
Maximal chance that the incidentaloma is a lethal cancer
Chance that the incidentaloma is NOT a lethal cancer
Lung (smokers)
50%
1.8%
3.6%
96.4%
Lung 
(never smokers)
15%
0.1%
0.7%
99.3%
Kidney
23%
0.05%
0.2%
99.8%
Liver
15%
0.08%
0.5%
99.5%
Thyroid (ultrasound)
67%
0.005%
< 0.01%
Ø  99.99%
.


When you reflect on the data in this table, it should be clear to the average person that, if an "incidentaloma" is discovered while some imaging test is done for another purpose, this result should simply be ignored. Otherwise you risk biopsy or surgery for no reasonable expectation of benefit.

COMMENT: I have been citing examples of these kinds of problems for years, but Dr. Welch puts them all together in one easy to read book with tables and diagrams that makes this otherwise dense information very accessible. While he makes a clear case that our traditional (and rather frivolous) approach to screening and diagnosis for these diseases poses significant hazards to your health, he provides less guidance on another approach to health promotion and disease avoidance other than better consumer information. Here is where my approach to prevention through the "Formula for Health" really shines.



    Adopting the 5 simple health habits identified in the "Formula for Health" has been shown in 13 major observational studies and 1 randomized controlled trial to be associated with benefits of the magnitude illustrated in the second poster. This approach requires no screening test, no blood testing or imaging, and creates no risk of overdiagnosis. In fact, it represents the maximum that you can do to improve your overall health. The problem with our modern medical technology is that "overdiagnosis" (with subsequent treatment without benefit) has become a bigger problem than the diseases they were designed to avoid. We have to find another way. A healthy lifestyle (The Formula for Health) is this way.

References:

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Wednesday, April 11, 2012

WHAT DO YOU KNOW ABOUT CANCER?

A VIEW FROM THE OFFICE



WHAT DO YOU KNOW ABOUT CANCER?

     Last week I wrote about the limited knowledge that most physicians have about cancer incidence, survival rates, and the effects of screening tests. Numerous studies indicate that a majority of patients base their decisions to be screened on their doctors' advice. Unfortunately, if doctors don't know much, your decision won't be very good. The only way to correct this is to try to know a little bit more about cancer yourself. So what do you need to know to make good cancer risk assessments and screening decisions?
     You need to know some basic epidemiologic facts about each type of cancer. In the old days, this information used to be hard to come by, but now it's all available instantly with a simple Google search. Let's consider several of the major cancers that people often get screened for. Here is a table that lists the core information you would like to know in order to make a decision on testing. 



Type of cancer
Incidence
Test: % of negative test results that are true
Test: % of positive test results that are false
Reduction in relative risk of dying of this cancer after testing.
Effect of testing on chances of being alive in 10 years.
Breast cancer
3 in 100 for each decade after 50 in average risk women
Mammogram: 90%
Mammogram: 2% (each time)
16% with serial testing every 2 years
0
Colon  cancer
57/100,000 in men at age 50; 150/100,000 at age 80.
Stool blood test: 30%
2%
15% with annual testing
0
Prostate cancer
8 in 100 at age 50;  37 in 100 at age 70
PSA:  80% (for result > 4)
6%
0
0























     If you are considering having a test for cancer, you want to know, first, How common is this type of cancer in persons like me? You also want to know what test are they using and how good is this test. The effectiveness of such tests are rated and compared by telling you how reliable a finding of a negative result is (i.e., How much confidence can you place in a negative test result indicating that you do not have this kind of cancer?) and the chances of having a positive test result that is not due to cancer. The simple fact is that no test rules out your chance of having cancer by 100%, and all tests have a number of false positive results that cause much anxiety but no disease. Finally, you want to know that there have been studies done to assess this screening technique and that it does in fact, after a number of years, reduce your chance of getting one of these cancers.
      In the table above we see that for an average woman, her risk of being diagnosed with breast cancer over any 10-year period after age 50 is about 3%. If she gets a mammogram regularly (at least every 2 years), she can reduce this risk by about 16%;  that is, after testing, her risk for a 10-year period will be 2.5%. This has to be compared to the risk of a false positive test result, which occurs in 2% for every mammogram performed; if you get several mammograms (e.g., the screening program calls for at least 10), then your risk of a false positive result is multiplied, and is 20% over 20 years if you get 10 mammograms. Each woman has to decide for herself whether she can accept this relatively high risk of a false-positive result in comparison to the relatively small benefit (2.5% absolute risk reduction over 20 years). Finally, every one undergoing any cancer screening test has to be aware that getting all the recommended tests is likely (but not guaranteed--note the result for prostate cancer screening with a PSA test) to offer a lower risk of dying of this type of cancer, but will, in fact, not insure that you live any longer overall than a person who does not get the screening test. In technical language, this means that there is no reduction in "all-cause mortality" for any of the common cancer screening tests.
     For women considering having a mammogram they should be aware that very recent studies have suggest that that absolute reduction in deaths from breast cancer is reduced by only 1 person per 2000 by screening, and the chance of having a cancer incorrectly diagnosed and treated is around 20-25%
     A group of widely respected medical experts (the Cochrane Collaboration folks) have put together a nice summary of the basic facts needed to make the breast cancer screening decision--"What you always wanted to know about breast screening". 

     Colon cancer screening poses the problems that the disease is considerably rarer than breast cancer (only about 50 cases per 100,000 persons at age 50, increasing to about 150 cases per 100,000 by age 80), that the test (stool testing for blood) is not very good (it reliably detects only about 30% of actual cancers, and gives a false positive result in 2% of persons tested every time it is used; this is a lot when you screen a large population. For example, if 100,000 persons were screened at age 50, there would be 57 true positive tests, and 2000 false positive tests). All of these false positive results have to be evaluated with additional testing (colonoscopy). The final disadvantage is that people just don't like having the necessary follow-up test for a positive result (the colonoscopy), which requires a full day of bowel preparation (total bowel wash-out) and a full-day lost from work or home on the day of the test, since sedation is used.

     Prostate cancer screening is the most curious case since there really is no good evidence that the test reduces even your relative risk of dying of prostate cancer because this disease is so common in men and often just sits there for many years without causing any problem at all.

     So this is the summary of the kind of basic information you should know before undergoing any cancer screening test. Because there are so many studies demonstrating that most physicians do not actually know or understand these facts, I am afraid I have to suggest that you look them up yourself.

THE PROBLEM OF BIAS

     Above I have discussed the real risks of getting these cancers and your chances of living longer, if you are diagnosed with one. The truth, however, is that most people (including both physicians and consumers) are not driven primarily by the real risks. They are driven by perceived risk--something tantamount to a gut feeling that one is likely to get such a cancer and this risk can be abated or avoided by a screening test. To illustrate how much of a problem the overperception of risk is, consider this chart from a 2010 publication.(1)



     For purposes of this graphic, you are a "participant." What the chart shows is the risk of dying of each cancer and the risk of being diagnosed with each cancer as estimated by the "participants" in a screening program compared to the actual risks as demonstrated by epidemiological studies (SEER). The dark gray bar shows participants estimates of their chance of dying of each cancer, if they have it, and the black bar shows their estimate of their chances of getting each cancer. Compared to the actual risks demonstrated in studies, participants tend to dramatically overestimate their risk both of getting these diseases and of dying from the disease, if they do get it. This fact then induces them to undergo testing whether or not the testing is in fact very effective.
     As I showed in my last blog, physicians are prone to very similar biases. They are inappropriately influenced in favor of testing by reported increases in "5-year survival" even though this means nothing about the actual effectiveness of a test. More than half of physicians are not aware that screening will always lead to an apparent increase in "5-year survival" (because cancers are detected earlier) that does not necessarily imply any reduction in mortality at all. While "5-year survival" is a critically important measure for different treatments for diagnosed cancers, it has no relevance to the assessment of screening effectiveness; a majority of physicians do not know this and will provide inappropriate endorsements of screening tests when told that 5-year survival was noted to increase after starting a screening program. In the referenced study below, only 1 of 65 physicians was aware that screening consistently leads to "overdiagnosis"--imputing a diagnosis of cancer to someone who was never at risk of dying from it.

     So what's the bottom line in cancer screening? There are really only two facts you want to know. First, what is the absolute reduction in your risk of dying of a cancer for which you have been screened?

For some common cancers, here are these numbers:

Breast cancer: The absolute reduction in risk of dying from breast cancer through screening is 1 per 2000.

Colon cancer: The absolute reduction in the risk of dying of colon cancer through screening at age 50 is about 10 cases per 100,000 persons screened. For persons being screened at age 70, the absolute reduction in the risk of dying is about 25 per 100,000 persons screened.

Prostate cancer: The absolute reduction in the risk of dying of prostate cancer through screening is 0.

Cervical cancer: The absolute reduction in the risk of dying of cervical cancer through screening with Pap smears is 3 per 100,000.

Melanoma: There is no evidence that screening programs reduce the absolute risk of dying from melanoma.

The other fact you want to know is, What is your chance of actually living longer due to undergoing these screening tests? Here are the relevant numbers:

Breast cancer: There is no increase in your total expected lifespan from breast cancer screening with mammography.

Colon cancer: There is no increase in your total expected lifespan from colon cancer screening with either the fecal blood test or colonoscopy.

Prostate cancer: There is no increase in your total expected lifespan from prostate cancer screening with the PSA test.

Cervical cancer: There is no increase in your total expected lifespan from cervical cancer screening with Pap smears.

Melanoma: There is no increase in your total expected lifespan from melanoma screening of the skin.

     Well, those are the facts. Now you can make your decision.



References:  Hoffman RM et al. Decision-making processes for breast, colorectal, and prostate cancer screening: results from the DECISIONS study. Med Decis Making 2010; 30(5 Suppl(): 53S-64S. doi: 10.1177/0272989X10378701
    

Tuesday, April 3, 2012

What Doctors Don't Know about Cancer Screening and You Should!

A VIEW FROM THE OFFICE


WHAT DOCTORS DON'T KNOW ABOUT CANCER SCREENING 
AND YOU SHOULD!

     Here are a few examples of results from cancer screening studies. See what you think.

#1:  The lung cancer example: "Imagine a group of patients in whom cancer was diagnosed because of symptoms at age 67 years, all of whom die at age 70 years. Each patient survives only 3 years, so the 5-year survival for the group is 0%. Now imagine that the same group undergoes screening. Screening tests by definition lead to earlier diagnosis. Suppose that with screening, cancer is diagnosed in all patients at age 60 years, but they nevertheless die at age 70 years. In this scenario, each patient survives 10 years, so the 5-year survival for the group is 100%." Sounds better, doesn't it? But it's not. "Yet, despite this dramatic improvement in survival rate (from 0% to 100%), nothing has changed about how many people die or when."

#2: The breast cancer example: "[E]ven for mammography screening for breast cancer..., several analyses have demonstrated that the vast majority of women with screen-detected breast cancer have not had their lives saved by screening, but rather have been diagnosed early with no change in outcome or have been overdiagnosed [i.e., diagnosed with a cancer that was never going to do any harm]."

#3: The prostate cancer example: In a survey among practicing physicians, the authors of this report used actual data from prostate cancer screening studies but just referred to the condition as 'Disease X'. They asked the physician respondents to assume that the tests used for screening were noninvasive, free, and detected cases of cancer for which treatment, such as surgery, exists. The effect of the test was described in terms of 5-year survival, and, in another scenario, the effect of the same test for 'Disease Z' was described by showing its effect on the death rate from this cancer.
     The result for the test for disease X was described as showing a 68% survival rate without screening and a 99% survival rate with screening.
     The result for the test for disease Z was described as resulting in 2 deaths per 1000 persons without screening vs. 1.6 deaths per 1000 persons with screening.
     Remember, both of these results apply to prostate cancer. They are just different ways of looking at the same data. Which result appears better to you?
     The key here is that earlier screening will ALWAYS detect more cases, and more early cases, but this fact in and of itself does not imply any improved outcome. Improved outcomes need to be determined by randomized controlled clinical trials.
     In this example, the second way of looking at the result is actually the superior method. It shows that there is a small, but statistically significant difference in mortality, associated with the screening intervention. But what you don't know yet is whether there are any harms from the screening intervention. This is a particularly important question because the mortality benefit is so small (0.4 cases per 1000); any adverse effects might quickly outweigh that benefit. 
     The example in the survey went on to explain that earlier screening for prostate cancer ultimately resulted in an incidence of 46 cases per 1000 persons with screening vs. only 27 cases per 1000 persons without screening.  Since the mortality benefit is only 0.4 deaths per 1000 subjects, these data mean that 19 extra persons will be diagnosed with prostate cancer without receiving any mortality benefit. Thus they will go through biopsies, chemotherapy, surgeries, and complications of surgery including impotence and incontinence. Now think about it. If it was your life, would you want this test? It is precisely because of this problem that the United States Preventive Services Task Force (our national experts) recommended against any screening for prostate cancer with our currently available tests.

     Now let's look a little further at how the physicians in this survey interpreted the data they were given.

1. The primary care physicians demonstrated limited knowledge of what evidence might prove that a cancer screening test saves lives. About one half (47%) incorrectly said that finding more cancer cases in screened as opposed to unscreened populations provided such proof. 

2. Many physicians did not distinguish between irrelevant evidence for screening (e.g., improved survival rates) and relevant evidence (reduced cancer mortality): Nearly as many physician incorrectly believed that survival data proved that screening saves lives (76%) as believed that mortality data provide this proof (81%).

3. 80% of physicians said that the screening test supported by irrelevant evidence (5-year survival increased from 68% to 99%) 'saves lives from cancer,' whereas only 60% said this about the test supported by relevant evidence (cancer mortality reduced from 2 to 1.6 in 1000 persons.

4. Physicians were also three times more likely to say they would 'definitely recommend' the test that improved 5-year survival compared with the one that reduced cancer mortality (69% vs 23%).

5. After seeing the data on the test that improved 5-year survival, physicians were then shown how the screening test increased the proportion of cases of cancer detected at Stage I (from 36% without screening to 54% with screening). This information in fact provides little support for a screening test because even a harmful test--one that increased mortality--could increase detection of early-stage cancer. Nonetheless, 68% of physicians said this information made them 'more' or 'much more' likely to recommend the test. In addition, 57% now expected the screening to save more lives from cancer than they had initially estimated without this additional information.

6. After seeing the data on the test that reduced mortality, physicians were shown how the screening test increased cancer incidence (from 27 to 46 per 1000 persons over 5 years). 62% of physicians said the increased incidence made them 'more' or 'much more' likely to recommend the test. In fact, 50% now expected the screening to save even more lives from cancer even thought the increased incidence is irrelevant to mortality. Overall, 11% incorrectly endorsed the explanation that the 'screened group must have had more cancer risk factors.' 42% incorrectly believed that the 'decreased mortality is all the more impressive given the higher incidence' with screening. More than one half (58%) did not endorse the statement that "For every death prevented by screening, some people are diagnosed and treated with cancer Z unnecessarily..."

7. At the end of the scenario about the test that improved survival, physicians were presented with an explanatory note explaining that higher survival (or finding more cases of state I cancer) with screening does not prove that screening saves lives and that such proof can come only from a randomized trial demonstrating lower cancer mortality. Although 76% stated that they found the note helpful, it had an inconsistent effect; 29% said it made them more likely to recommend the screening test, and 21% said it made them less likely.

8. At the end of the scenario about the test that reduced cancer mortality and increased incidence, physicians were presented with an explanatory note that highlighted the possibility of over-diagnosis (that is, to prevent 1 death from cancer, as many as 47 additional people would be diagnosed unnecessarily). 80% found this note helpful, and 40% said it made them less likely to recommend the new test. However, 23% said it made them more likely to recommend the test. 

Now here is the way I like to express the relative effectiveness of cancer screening. I use it as a test for students and residents regularly.  It is simple. Just review the following table for the most commonly recommended screening tests for cancer.


Cancer Type
Relative Risk Reduction
Reduction in All-Cause Mortality
  Breast
 16% (USPSTF)
 0%
  Colon
 15% (USPSTF)
 0%
  Cervical
  40-60% (USPSTF)
 0%
  Prostate
  unknown (studies inconclusive)
 0%
  Skin
  unknown (studies inconclusive)
 0%

     The "relative risk reduction" means that with the screening test for cancer X your risk of dying of cancer X is reduced by this amount; thus breast cancer screening reduces your risk of dying of breast cancer by about 16%. What "Reduction in All-Cause Mortality" means is how many people are still alive at the end of a given period of time. What the number "0" indicates is that, when you consider all possible causes of death, NO ONE appears to be living any longer as a result of cancer screening. 
      Again, what this means is that for all our trouble no one, I mean, No one!, is living any longer when you look at all possible causes of death. Yes, they are having somewhat fewer deaths from breast, colon, and cervical cancer (if they comply with screening recommendations), but they are not living one single day longer. You have just rearranged the desk chairs on the Titanic.

     Most significant from this table, since no single cancer screening strategy reduces all-cause mortality at all, is its clear implication:  IF YOU CAN FIND ANY INTERVENTION THAT LEADS TO EVEN A 1-2% REDUCTION IN ALL-CAUSE MORTALITY, IT WILL DO FAR, FAR MORE GOOD THAN ALL OF THESE CANCER SCREENING INTERVENTIONS PUT TOGETHER!

     Thus, the further question to ask is: Do we have any such interventions that will reduce all-cause mortality?  And I have to say, "Of course, we do." Let's encourage a healthy lifestyle with our Formula for Health. Based on the 14 major observational studies of healthy lifestyle we can impute the following benefits to those who adopt all 5 healthy habits:
       This lifestyle strategy could reduce your overall risk of dying (all-cause morality) by 40-65%. The fact that it leads to 36-64% reductions in ALL cancers plus a 40-65% reduction in all cause mortality means that the adoption or maintenance of a healthy lifestyle is the SINGLE MOST EFFECTIVE THING YOU CAN DO TO REDUCE YOUR PERSONAL RISK OF CANCER.  And it's really pretty easy and inexpensive to promote. Just hand out my pretty little flyers (above) and take a minute or two to talk about it. It beats all the mammograms, FOBTs, sigmoidoscopies, colonoscopies, Pap smears, and colposcopies put together at far, far less cost. What's to think about? This is a no-brainer.
     Do something sensible to prevent cancer today!

Here is your strategy:




ADDENDUM:  I will be at the Portola clinic on Saturday, April 4th. I hope to see some of you there.

References:

1.  Wegwarth O et al. Do physicians understand cancer screening statistics? A national survey of primary care physicians in the United States. Ann Intern Med 2012; 156: 340-9.

2. Editorial: What we don't know can hurt our patients: Physician innumeracy and overuse of screening tests. Ann Intern Med 2012; 156: 392-3.



Tuesday, February 28, 2012

A VIEW FROM THE OFFICE




HOW DO YOU KNOW IF SOMEONE IS COMPETENT 
TO MAKE A DECISION FOR HEALTH CARE

    The determination of whether someone is competent to make their own decisions is very difficult. Over the last 20 years numerous experts have taken their best shots at designing algorithms or questionnaires to help primary care physicians to make this determination with relatively little success. In this article I am sharing the result of a recent study of the different instruments that have been developed for this.(1) The instrument that has been the best tested and validated is called the "Aid to Capacity Evaluation." A copy of this form is available as a free PDF file online and includes instructions for use.
     My reason for including this information in a consumer blog is because it is often too late to be practical if the family waits for a physician to do the evaluation. These kinds of decisions are best anticipated. Most relatives and friends of someone whose health is deteriorating to the point of being unable to make a quality decision for themselves are aware that in some areas of life the patient should not be left on his/her own. Reviewing this form allows family members to walk through the steps to assess the different areas of capacity/competence. Once family members get to the point of thinking this may be helpful, it is time to formally prepare a document expressing the patient's wishes for end-of-life care or other critical health decisions. Ideally, this can be done before the patient becomes incompetent across the board.
     The legal background for this issue is that all adult patients (over the age of 18) are presumed by law to be competent. Even if a patient has severe chronic disease, even chronic mental illness like schizophrenia, the initial legal presumption is that they are capable of making their own decisions. In general, psychiatric patients cannot be compelled to take their medications. Psychiatric patients are presumed capable of determining whether they want a surgical procedure or not, even if a "reasonable" person of the same age would reach a different conclusion. They are not required to make the "correct" decision (whatever that is). The decision just needs to reflect a minimal understanding of the problem or issue, a clear and consistent preference (whether logical or not), and not be obviously impaired by other illness, particularly depression or delusions. A person with a chronic mental illness such as schizophrenia or dementia can be quite capable of expressing a meaningful decision about a surgical treatment or diagnostic test even when they care clearly incompetent to manage their own finances, hygiene, or usual activities of daily living. So to say a person has dementia, by itself, has no specific implications for their capacity to make medical decisions.
     An individual can be deprived of their right to make their own decisions only by an authorized police official (e.g., for a 5150 Psychiatric hold for 72 hours to perform a formal evaluation of competence and safety) or judicial determination (a competency or custodianship hearing). The police action is only a temporary one. The judicial action obviously requires significant time to go through the steps of finding an advocate, reviewing relevant documents and witnesses, and scheduling a formal hearing on the court docket. As a practical matter, the legal system is simply not capable of responding quickly enough to assist in making decisions about an individual's competency to be helpful when it is needed. That is why it is so important that family members or anyone who takes part in the care or support of a patient proactively address these issues well in advance of acute illness or the need for something like nursing home placement when the patient says s/he does not want to go.
     I believe that the form below is very simple and clear to follow. A lay person can walk through the appropriate evaluation process for someone s/he is concerned about. It is so much better to have this process addressed early in the course of chronic illness, even by a lay person, than it is to wait until the situation is urgent and then try to have a doctor do it. Legally a doctor cannot make the determination that someone is not competent to make a decision. If an advance directive is not in place, then the legal process will have to be invoked.


THE AID TO CAPACITY EVALUATION

[Record observations that support your score in each domain, including exact responses of the patient.  
Indicate your score for each domain with a circle.]


1. Able to understand medical problem 
      (Sample questions: What problem are you having now? What problem is                
        bothering you most? Why are you in the hospital? Do you have (name
        problem)?)            

             YES                   NO                UNSURE
                                                                                            
        Observations:  ______________________________________________  
   
__________________________________________________________

2.  Able to understand proposed treatment 
     (Sample questions:  What is the treatment for [your problem]?
       What else can we do to help you? Can you have [proposed treatment]?

             YES                   NO                UNSURE
         
       Observations: ______________________________________________
        _________________________________________________________

3.  Able to understand alternative to proposed treatment (if any)
     (Sample questions: Are there any other [treatments]? What other
       options do you have? Can you have [alternative treatment]?

             YES                   NO                UNSURE                 UNDISCLOSED


       Observations: ______________________________________________
                                                                                                                                                   
      __________________________________________________________

4. Able to understand option of refusing proposed treatment 
      (including withholding or withdrawing proposed treatment)
       (Sample questions: Can you refuse [proposed treatment]? Can we stop
        [proposed treatment]?

             YES                   NO                UNSURE


        Observations:  _____________________________________________
        _________________________________________________________

5. Able to appreciate reasonably foreseeable consequences of
     accepting proposed treatment
(Sample questions: What could happen to you if you have [proposed
 treatment]? Can [proposed treatment] cause problems/side effects?
 Can [proposed treatment] help you live longer? )

             YES                   NO                UNSURE


       Observations:  _____________________________________________
        _________________________________________________________

6.   Able to appreciate reasonable foreseeable consequences of 
        refusing proposed treatment (including withholding or 
        withdrawing proposed treatment) 
        (Sample questions: What could happen to you if you don't have [proposed
        treatment]? Could you get sicker/die if you don't have [proposed treatment]?
        What could happen if you have [alternative treatment]? (If alternatives are available)

             YES                   NO                UNSURE


       Observations:  _____________________________________________
        _________________________________________________________

(Note: for questions 7a and 7b, a “yes” answer means the person’s decision is affected by depression.)


7a. The person's decision is affected by depression
       (Sample questions: Can you help me understand why you've decided to
        accept/refuse treatment? Do you feel that you're being punished?  Do
        you think you're a bad person? Do you have any hope for the future?
       Do you deserve to be treated? )

             YES                   NO                UNSURE


      Observations:  _____________________________________________
        _________________________________________________________

7b. The person's decision is affected by psychosis
       (Sample questions: Can you help me understand why you've decided to
        accept/refuse treatment? Do you think anyone is trying to hurt/harm
        you? Do you trust your doctor/nurse? )
             YES                   NO                UNSURE


       Observations:  _____________________________________________
        _________________________________________________________


Overall Impression 


Definitely capable     Probably capable     Probably incapable     Definitely incapable 


Comments:
(for example: need for psychiatric assessment, further disclosure and discussion with patient
or consultation with family)

The initial ACE assessment is the first step in the capacity assessment process.  If the ACE is definitely or probably incapable, considerable treatable or reversible causes of incapacity.  Repeat the capacity assessment once these factors have been addressed.  If the ACE result is probably incapable or probably
capable, then take further steps to clarify the situation.  For example, if you are unsure about the person’s ability to understand the proposed treatment, then a further interview which specifically focuses on this area would be helpful.  Similarly, consultation with family, cultural and religious figure and/or psychiatrist,
may clarify some areas of uncertainty.

Never base a finding of incapacity solely on your interpretation of domain 7a and 7b.  Even if you are sure that the decision is based on a delusion or depression, we suggest that you always get an independent
assessment.

Time taken to administer ACE:   ______ minutes
Date:  ______________
Assessor: _______________________________

COMMENT: You will notice that the form records its conclusion in a "fuzzy" way--"probably" vs. "definitely" capable or incapable. This is as good as it gets. If you need to seek more clarity, you seek more input (additional evaluations using the same instrument from other people who know the patient well or other professionals with special expertise in these kinds of assessments. Just remember that no expert is qualified, on his own, to make a determination that a patient is not competent to make a medical decision. In the end, only a court can do this if the patient has not previously appointed a "health care proxy" to make these decisions when s/he should become no longer able.


References:


1. Sessums LL, Zembrzuska H, Jacksoni JL. Does this patient have medical decision-making capacity? JAMA 2011; Jul 27; 306(4): 420-7.

Friday, February 17, 2012

Reliable Quick Answers to Medical Questions on the Web

A VIEW FROM THE OFFICE


RELIABLE QUICK ANSWERS TO MEDICAL QUESTIONS ON THE WEB:

WELCOME TO HEALTHTAP!

     Two weeks ago I read in the Sunday New York Times an article about a web-based consumer information service called "HealthTap." It invites both consumers and physicians to join. Consumers ask the questions. Volunteer physicians provide the answer. HealthTap started its Web site last May. It has signed up more than 9,000 physicians and is adding 100 a day. The site does not carry advertising. "Users can follow particular doctors and topics of interest; new answers related to these are displayed in an “activity feed” shown when users log on to the site. The site offers a peer-based reputation system of its own devising. Next to each answer, users see the number of doctors who agree; with a click, they can see who the approving doctors are, as well as something that HealthTap calls a “reputation level,” which is built by accumulating HealthTap awards, “Agrees” from fellow physicians and other measurable activities at the site."  

Here is a screenshot from the patient side of the website:



Here is a screenshot from my physician side of HealthTap.



      Probably the strongest feature about this site for consumers is the ability to "follow" the opinions of certain physicians who give precise, clear, practical answer. [Some of the answers are indeed too brief to be helpful.] You will be notified of new responses for the physicians that you follow. [You are certainly welcome to follow me.] 
     For the physicians it is an excellent opportunity to reach out to patients outside of the office and to do good for the community (in fact, a very big community--the whole internet!). It can also sharpen physician skills in communication. Trying to be helpful, succinct, and clear in only 400 characters [the limit for each answer] is a good mind-sharpening challenge. I find it an excellent way to both learn something and be useful in the few minutes between patients in the office. It is always informative to see the kinds of things that patients are concerned about but may not bring to the office. Some of the questions are distinctly challenging and send me to do online research so that we can both be educated at the same time. In my opinion, any way that a doctor can make more contact with the community is a good thing. 
     HealthTap offers a very sociable and time-efficient way of getting in touch with a treasure trove of physicians. Try it!


A NOTE TO MY FRIENDS IN PLUMAS COUNTY:  I will be returning to do a Saturday morning clinic on March 3rd at the Portola Clinic. The plan is for me to come back for a clinic session on the first Saturday of each month. I look forward to seeing you there.




Dr. Colin Kopes-Kerr, MD